Ignite Creation Date:
2025-12-24 @ 9:21 PM
Ignite Modification Date:
2025-12-28 @ 3:50 AM
Study NCT ID:
NCT05790304
Status:
COMPLETED
Last Update Posted:
2025-03-25
First Post:
2023-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Investigate Hepatic Impairment on PK, Safety, Tolerability of Camizestrant in Post-Menopausal Female Subjects
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
A Phase I, Single Dose, Non-Randomised, Multicentre, Open-Label, Parallel Group Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of Camizestrant in Post Menopausal Female Subjects
Status:
COMPLETED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This will be a Phase I, multicentre, single-dose, non-randomized, open-label, parallel-group study to examine the PK, safety, and tolerability of camizestrant 75 mg in post-menopausal female participants with moderate or severe hepatic impairment compared with post-menopausal female participants with normal hepatic function.
Participants will be enrolled within the following groups based on their CP classification score as determined at screening:
* Group 1: Matched-control healthy participants with normal hepatic function.
* Group 2: Participants with moderate hepatic impairment (CP Class B, score of 7 to 9).
* Group 3: Participants with severe hepatic impairment (CP Class C, score of 10 to 15).
Participants will be enrolled within the following groups based on their CP classification score as determined at screening:
* Group 1: Matched-control healthy participants with normal hepatic function.
* Group 2: Participants with moderate hepatic impairment (CP Class B, score of 7 to 9).
* Group 3: Participants with severe hepatic impairment (CP Class C, score of 10 to 15).
Detailed Description:
This will be an open-label, non-randomized, multicentre, parallel-group, single-dose study to investigate the PK, safety, and tolerability of camizestrant 75 mg administered orally to post-menopausal female participants with moderate or severe hepatic impairment compared to control post-menopausal female participants with normal hepatic function. A total of approximately 14 participants with hepatic impairment (8 participants with moderate impairment and 6 participants with severe impairment per CP classification) and 8 to 14 matched-control healthy participants with normal hepatic function are planned to be enrolled, with the goal of having approximately 8 participants with moderate impairment and approximately 6 participants with severe impairment and sufficient matching participants with normal hepatic function complete the study. All participants will receive a single oral dose of 75 mg camizestrant on Day 1 following an overnight fast. Study intervention will be administered orally with approximately 240 mL of water.
Child-Pugh scoring, detailed in Table 3, will be used to determine the level of hepatic impairment. Participants will be enrolled into the following groups based on their CP classification score as determined at screening:
* Group 1: Matched-control healthy participants with normal hepatic function.
* Group 2: Participants with moderate hepatic impairment (CP Class B, score of 7 to 9).
* Group 3: Participants with severe hepatic impairment (CP Class C, score of 10 to 15).
Child-Pugh scoring, detailed in Table 3, will be used to determine the level of hepatic impairment. Participants will be enrolled into the following groups based on their CP classification score as determined at screening:
* Group 1: Matched-control healthy participants with normal hepatic function.
* Group 2: Participants with moderate hepatic impairment (CP Class B, score of 7 to 9).
* Group 3: Participants with severe hepatic impairment (CP Class C, score of 10 to 15).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2022-502277-41-00 | OTHER | EMA- CTIS | View |